Adjustable nasal prong and headgear assembly

ABSTRACT

The invention is directed to a ventilation interface, which includes a cannula having one or more nasal prongs, a ventilation tube connected to the cannula and headgear. The cannula is secured onto the patient through one or more arced couplers positioned between the cannula and headgear. The cannula has a first side wall, a second side wall and a top wall which form a reservoir. The top wall includes a first portion, a second portion and a notch positioned between the first portion and second portion. The ventilation tube includes one or more bleed ports and provides breathable gas to a patient. The headgear includes a first strap and a second strap. The first strap includes a first portion and second portion that contains two or more slots to connect the second strap. Each portion of the first strap includes an inner layer and an outer layer.

FIELD OF THE INVENTION

This invention is directed to nasal prong and headgear assemblies foruse when delivering breathable gas in treating various respiratoryissues including, but not limited to, sleep apnea and in other forms ofassisted respiration. More specifically, the invention relates to aheadgear capable of pivotally attaching with the cannula of the nasalprong through one or more arced couplers.

BACKGROUND OF THE INVENTION

Ventilation interfaces are used for various applications. One suchapplication involves current treatments for sleep apnea. Sleep apnea isa common sleep disorder characterized by sustained pauses in breathingduring sleep. The disorder occurs in both infants and adults. Eachepisode, known as an apnea, can last more than ten seconds and resultsin blood oxygen desaturation. A clinical diagnosis of sleep apnea isdefined as five or more episodes per hour. There are three types ofsleep apnea: central, obstructive, and complex.

Obstructive sleep apnea (OSA) constitutes the most common form of sleepapnea. OSA is a medical condition that includes repeated, prolongedepisodes of cessation of breathing during sleep. During a period ofwakefulness, the muscles of the upper part of the throat passage of anindividual keep the passage open, thereby permitting an adequate amountof air (which contains oxygen) to flow to the lungs. During sleep, thethroat passage narrows due to relaxation of the muscles. In individualshaving a normal sized throat passage, the narrowed throat passageremains open enough to permit a sufficient level of oxygen to flow intothe lungs. However, in individuals with smaller sized throat passages,the narrowed throat passage prohibits adequate amounts of oxygen to flowinto the lungs.

In addition, an obstruction, such as a relatively large tongue, anocclusion in the upper respiratory track or an odd-shaped plate can alsoprohibit a sufficient amount of oxygen to flow to the lungs—thus alsoresulting in OSA. OSA can result in a variety of medical conditionsincluding daytime drowsiness, headache, weight gain or loss, limitedattention span, memory loss, poor judgment, personality changes,lethargy, inability to maintain concentration and/or depression.

Other medical conditions can also prevent individuals, including adultsand infants, from receiving an adequate amount of oxygen to the lungs.For example, an infant who is born prematurely can have lungs that arenot developed to an extent necessary to receive adequate amounts ofoxygen. Further, prior to, during, and/or subsequent to certain medicalprocedures and/or medical treatments, an individual can be unable toreceive an adequate amount of oxygen. Under these circumstances, it isknown to use a ventilation interface to apply a positive pressure to thethroat of the individual, thereby permitting an adequate amount ofoxygen to flow into the lungs.

In known ventilation interfaces, oxygen and/or room air containingoxygen is delivered through the mouth and/or nose of the individual. Themost common form of positive pressure treatment for OSA is use of acontinuous positive airway pressure (CPAP) device. A CPAP device forcesa pressurized breathable gas into the patient's respiratory track andallows air to pass the obstruction(s) and/or occlusion(s). Other formsof positive pressure delivery exist, such as bi-Level positive airwaypressure (BiPAP) in which a relatively higher positive pressure ismaintained during inspiration and a relatively lower positive pressureis maintained during expiration, and intermittent mechanical positivepressure ventilation (IPPV) in which a positive pressure is applied whenapnea is sensed (i.e., the positive airway pressure is appliedintermittently or non-continuously). With all these types of therapy, apositive pressure device (i.e., flow generator) connects via aventilation tube to a ventilation interface. The interface connects toeither the patient's nose, mouth or both orifices.

Various interfaces have been developed for positive pressure, and morespecifically CPAP therapy. These include various shaped full-face masks,nasal masks, nasal prong masks, oral masks and hybrid masks (i.e., thosemasks that combine masks such as having an oral cavity with nasalprongs). Nasal prongs offer one popular form of interface for use withCPAP therapy because they are relatively small, less bulky and morecomfortable for many patients to wear for long periods of time.

Nasal prongs can generally be separated into two types: nasal pillowsand nasal inserts. Nasal pillows typically abut against the openings ofa user's nares when in use and may not be inserted substantially withinthe nasal passages. Nasal inserts are typically positioned within thenasal passages of a user and may or may not abut against the nasalopenings. Embodiments and the principles thereof are contemplated forany nasal prong and the like, as will be readily recognized by onehaving ordinary skill in the art. Nevertheless, for illustrativepurposes in a non-limiting manner, exemplary embodiments are describedbelow in reference to nasal pillows.

A seal is maintained between the patient and the ventilation interfacethrough use of headgear. More specifically, the headgear of a nasalpillow assembly creates an upward force by compressing the nasal pillowsonto the nasal openings. This compression should be sufficient toeffectuate the seal without creating discomfort to the patient. Thesenasal pillow systems, unlike nasal mask and full-face mask interfaces,help reduce the risk of patients feeling claustrophobic while beingtreated for OSA through CPAP therapy. However, one issue with nasalpillows is that they have to be calibrated and properly fitted tomaintain an effective seal between the interface and patient, whilestill being comfortable to wear for long periods of time.

Various forms of nasal pillow and headgear assemblies have beendeveloped which attempt to address these design criteria. Two initialexamples of nasal pillow interfaces found in the prior art include U.S.Pat. No. 5,724,965 and U.S. Pat. No. 6,431,172. Both nasal pillowsystems require multiple part construction for the reservoir thatincludes both a hard plastic first component and a softer secondcomponent. Thus, the gas reservoir requires at least two parts, whichleads to various connecting points that can leak. Moreover, both theseprior art systems require complicated headgear, which increases the riskof the patient feeling claustrophobic. Moreover, these designs arecomplicated, difficult to calibrate and fail to allow easy adjustment bythe patient during use.

While more recent commercially available nasal pillow designs continueto provide alternative headgear and connection systems to calibrate thereservoir proximate to the patient's face, these systems still haveseveral drawbacks. Two such examples are the ResMed® Swift LT and theFisher & Paykel® Opus™ nasal pillows. Both require a two part cannulacomprised of: a rigid frame that connects with the ventilation tube anda second more pliable silicone base that has the nasal pillows.

The Swift LT interface includes a ratchet system, which can rotate andlock at various positions relative to the headgear to adjust the angleof the nasal pillows to the patient's face. Since the axis of theratchet system is well below the nasal pillows, the nasal pillows movein an arc relative to the axis. Therefore, any rotational adjustmentundesirably impacts how the user wears the headgear, and consequentlyforces the user to recalibrate and make further adjustments to theinterface and headgear to achieve a proper fit. Also, the toothed partof the ratchet system (which connects to the reservoir) is made of asoft rubber or silicone elastomer, which invariably will degrade andlead to stripping—thus inhibiting the ability to angle the pillowsrelative to the headgear and effectuate an effective seal between thenares and the patient. Moreover, the complicated design requires asignificant level of time and attention to adjust.

The Opus™ nasal pillow does not include a means at all to adjust theangle of the pillows relative to the headgear and therefore the user'sface. There are several other drawbacks to both the ResMed® Swift LT andthe Fisher & Paykel® Opus™ nasal pillows. Neither product allows theuser to quickly disconnect the cannula or to disconnect the cannulawhile maintaining the headgear in place. Also, both products requireextra parts to provide the adequate pillow sizes required to fitdifferent patients.

Accordingly, there is a need in the art of ventilation interfaces for anasal prong that allows for more simplified construction and thatincludes an effective means for adjusting and calibrating the interfacein relation to the patient to ensure long term comfort. In addition,there is a need in the art for an improved headgear that can connect tothe interface to allow a patient to easily assemble, disassemble, adjustand position the interface to ensure an effective seal with the nares.Finally, there is a need in the art to simplify the nasal prongofferings without compromising sealing and comfort. In short, the designshould allow more comfortable long term use, require less assembly andbe easily calibrated.

SUMMARY OF THE INVENTION

The present invention solves many of the problems with currentventilation interfaces, including nasal prong and headgear designs. Inone embodiment of the invention, the ventilation interface may include asingle-body constructed cannula made of silicone elastomer having afirst side wall, a corresponding second side wall in parallel relationto the first side wall, a top wall, a front wall and a back wall whichform a reservoir. The top wall of the cannula may include a firstportion, a second portion and a notch positioned between both portions.Integrally attached to both portions is a set of two nasal prongs, thefirst nasal prong positioned on the first portion while the second nasalprong is located on the second portion of the cannula. Connected to thecannula through a ball-and-socket connector is a ventilation tubecapable of providing pressurized breathable gas to a patient. Positionedbetween the ball-and-socket connector and the ventilation tube is aconnector that contains one or more bleed ports.

Headgear may be attached to the cannula through two arced couplers. Afirst arced coupler includes a curved female sleeve located on the firstside wall of the cannula and a corresponding first curved male tineattached to the headgear. Similarly, a second arced coupler includes acurved female sleeve located on the second side wall of the cannula anda second curved male tine which is also attached to the headgear.

The invention is further directed to an improved headgear that maycomprise a first strap and a corresponding second strap. The first strapincludes a first portion and a second portion, the second portionmirroring the size and orientation of the first portion. Each portion ofthe first strap may include a flexible inner layer and correspondingrigid outer layer. Each inner layer has a first section, a secondsection and a corresponding third section of material. The inner layermay be made of single piece construction.

The second section of the flexible inner layer is oriented at an anglebelow the first section, while the third section is oriented at an angleabove the second portion. The third section connects to the cannulathrough the arced coupler. The outer layer has one or more slots.Optionally, the shape and configuration of the outer layer mirrors thatof the inner layer. More specifically, the outer layer includes a firstslot and a corresponding second slot, the second slot having a positionand angle different than the first slot such that both slots are capableof positioning the second strap at a different angle about a patient'shead.

The second strap of the headgear includes a first end and acorresponding second end, both ends having a hook-and-loop fastenersufficient to attach the second strap to one or more slots located onthe outer layer of the first strap. A tube holder is positioned on themiddle portion of the second strap. This tube holder has a sufficientsize and dimension to maintain and secure the ventilation tube.

In another embodiment of the invention, the headgear may attach to thecannula through a male member and female slot system—instead of a sleeveand tine assembly. More specifically, the arced coupler may include amale member located on a side wall of the cannula. The male member has asufficient size and dimension to as to fit within and pivotally engage afemale slot located on the headgear. Moreover the unique shape of thearced coupler allows the user to pivot the cannula about an axis toproperly seat the ventilation interface proximate to the nares toeffectuate an improved seal.

In yet another embodiment of the invention, the headgear may engage thecannula through a pin and receptacle configuration. More specifically,the back wall of the cannula includes a receptacle. In addition, theheadgear may include a rigid pivot pin. The pin has a sufficient sizeand dimension to rest within and engage the receptacle.

In still yet another embodiment of the invention, the headgear mayattach to the cannula of the ventilation interface through at least oneconnecting portion, which includes a center strap.

In addition, nasal prongs may also be detachably coupled with theventilation interface. Each detachable nasal prong includes at least twoprong portions. The prong portions offer the patient different sizes orstyles of nasal prongs in one component. In addition (or alternatively),the nasal prongs can have an upper portion that is located at the distaltip of the nasal prong. The upper portion is adjustable to differentconfigurations.

BRIEF DESCRIPTION OF THE DRAWINGS

For a fuller understanding of the invention, reference is made to thefollowing detailed description, taken in connection with theaccompanying drawings illustrating various embodiments of the presentinvention, in which:

FIG. 1 is a perspective view of the cannula and headgear assembly;

FIG. 2 is an exploded view of the various components of the cannula andheadgear assembly;

FIG. 3A is a front perspective view of the cannula;

FIG. 3B is a back perspective view of the cannula;

FIG. 3C is a front perspective view of the cannula and the ventilationtube;

FIG. 4 is a cross-sectional view of the cannula and the ventilationtube;

FIG. 5A is a side view of the cannula and headgear assembly;

FIG. 5B is a front view of the cannula and headgear assembly;

FIG. 6A is a perspective view showing how the headgear connects to twoarced couplers located on the cannula;

FIG. 6B is a cross-sectional view showing how the headgear connects tothe cannula;

FIG. 6C is a cross-sectional view showing the headgear secured to thecannula;

FIG. 6D is a perspective view of an alternative embodiment showing howthe headgear connects to the cannula;

FIG. 6E is a side view of the alternative embodiment showing how theheadgear connects to the cannula;

FIG. 7A is a perspective view of a detachable nasal prong;

FIG. 7B is a cross-sectional view of the nasal prong shown in FIG. 7A;

FIG. 8A is a perspective view of another embodiment of a detachablenasal prong;

FIG. 8B is a cross-sectional view of the nasal prong shown in FIG. 8A;

FIG. 9A is a perspective view of an alternative embodiment of a nasalprong;

FIG. 9B is a perspective view of the cannula configured to interfacewith detachable nasal prongs;

FIG. 10A is a cross-sectional view of one configuration of thealternative nasal prong embodiment shown in FIG. 9A;

FIG. 10B is a cross-sectional view of a second configuration of thealternative nasal prong embodiment shown in FIG. 9A.

FIG. 10C is a cross-sectional view of a third configuration of the nasalprong embodiment shown in FIG. 9A.

FIG. 11A is a perspective view of an alternative embodiment showing howthe headgear connects to the cannula.

FIG. 11B is a cross-sectional view of the alternative embodiment shownin FIG. 11A.

FIG. 12 is a perspective view of a handle applied to a cannula andheadgear assembly.

FIG. 13 is a perspective view of yet another embodiment of the headgear.

DETAILED DESCRIPTION OF THE INVENTION

The present invention will now be described more fully hereinafter withreference to the accompanying drawings, in which preferred embodimentsof the invention are shown. This invention may, however, be embodied inmany different forms and should not be construed as limited to theembodiments set forth herein. Rather, these embodiments are provided sothat this disclosure will be thorough and complete, and will fullyconvey the scope of the invention to those skilled in the art. Likenumbers refer to like elements throughout. The terms “embodiment of theinvention,” “embodiments”, or “invention” do not require that allembodiments of the invention include the discussed feature, advantage,or mode of operation.

The invention described in detail below and in the figures is designedto cooperate and be used with any form′ of ventilation interface for theadministration of breathable gas having a headgear and some form offacial seal. Such ventilation interfaces can include any form of facialmask, nasal prong mask, so called “hybrid” masks or other style andshaped masks having an oral cavity and some form of nasal prong—whichwill be readily understood by those of ordinary skill in the art.Accordingly, the ventilation interfaces described and disclosed inUnited States Patent Application Nos. 2006/10124131 (Chandran et al.),2006/0174887 (Chandran et al.), 2007/10272249 (Chandran et al.), and2008/0011305 (Chandran et al.) are incorporated by reference herein intheir entireties.

Nasal prongs can generally be separated into two types: nasal pillowsand nasal inserts. Nasal pillows typically abut against the openings ofa user's nares when in use and may not be inserted substantially withinthe nasal passages. Nasal inserts are typically positioned within thenasal passages of a user and may or may not abut against the nasalopenings. Embodiments and the principles thereof are contemplated forany nasal prong and the like, as will be readily recognized by onehaving ordinary skill in the art. Nevertheless, for illustrativepurposes in a non-limiting manner, exemplary embodiments are describedbelow in reference to nasal pillows.

The Overall Ventilation Interface

One embodiment of the invention includes a ventilation interface 100illustrated in FIGS. 1 and 2. First turning to FIG. 1, the interface 100is comprised of three components: a ventilation tube 200, a cannula 300and headgear 500. Preferably made of a polymer or composite, theventilation tube 200 is soft, bendable and flexible. The ventilationtube 200 contains a plurality of circular ridges 210 (in parallelrelationship to one another) which helps ensure the ventilation tube 200does not kink or become bent so as to reduce the pressure of suppliedbreathable gas. In other embodiments, the ridges 210 could be helicallyswept over at least a portion of the length of the ventilation tube 200.

The ventilation tube 200 includes a first end 230 and a correspondingsecond end 240. Located at the first end 230 of the ventilation tube 200is a rigid fitting 250, typically made of hard plastic, which allowsconnection to the flow generator (not shown). Rigid fitting 250preferably is a swivel coupling, comprised of at least two parts. Thesecond end 240 of the ventilation tube 200 connects with the cannula300. In embodiments, the ventilation interface 100 may have more thanone ventilation tube 200 and the rigid fitting may be in the form of a“Y” coupler.

FIG. 1 further illustrates the salient components of the headgear 500(discussed in detail below). As shown, the headgear 500 includes a firststrap 510 and a second strap 520. The first strap 510 includes an innerlayer 511 and an outer layer 512. The outer layer 512 extends throughoutat least a portion of the inner layer 511 of the first strap 510. Theinner layer 511 should be flexible and made of a compressible andbendable material, which can include, but is not limited to, neoprene.Other similar material known to those of ordinary skill in the art canalso be used. The outer layer 512 is preferably more rigid than theinner layer 511, but should still be flexible to allow conformance tothe curvature of the patient's face (not shown). The outer layer 512 ofthe first strap 510 is preferably made of a polymer, thin flexiblemetal, or composite.

The first strap 510 of the headgear 500 includes a first portion 530 anda corresponding second portion 540. The first portion 530 connects tothe second portion 540 through connector 550. The connector 550 allowsfor adjustment (i.e., loosening and tightening) of both the firstportion 530 and second portion 540 onto the face. The connector 550 ispreferably plastic and capable of maintaining both portions 530 and 540in a compressed state on the patient's face.

FIG. 1 also illustrates the second strap 520 of the headgear 500. Thesecond strap 520, like the inner layer 511 of the first strap 510, issoft, flexible and preferably includes neoprene. The second strap 520has a middle portion 523. Positioned on the middle portion 523 of thesecond strap 520 is a tube holder 524. The tube holder 524 is ofsufficient size and dimension so as to hold and maintain the ventilationtube 200 while the interface 100 is worn by the patient.

The tube holder 524 may be constructed of a polymer that allows theventilation tube 200 to fit or snap into it. The tube holder 524 mayalso be formed of a material that allows it to wrap around and hold theventilation tube 200, such as fabric with hook and loop closure ends. Inembodiments, the tube holder 524 may be located on any portion of theheadgear 500 to allow the patient to route the ventilation tube 200 indifferent positions.

As shown in FIGS. 1 and 2, the cannula 300 is connected to theventilation tube 200. While there exist a variety of means by which theventilation tube 200 can connect to the cannula 300, one preferredembodiment of the ventilation interface 100 includes a connector 270located on the second end 240 of the ventilation tube 200. As shown, oneform of connector 270 contemplated by the invention is a ball-and-socketconnector. Such embodiment would allow connector 270 to have threedegrees of freedom with the cannula 300 to allow a large degree of roll,pitch and yaw. Other embodiments contemplate having the connector 270and cannula 300 couple as a swivel to allow 360 degrees of rotation andone degree of freedom.

As illustrated in FIG. 1 and FIG. 2, a socket 260 is located between thecannula 300 and connector 270. Such connector 270 has a ball 261 on thedistal end that engages the socket 260. Such ball 261 and socket 260 arepreferably made of hard plastic. The various degrees of freedom allowthe ventilation tube 200 to be positioned below, along, or above thepatient's face.

While the connector 270 shown in FIG. 2 is “L” shaped akin to an elbow,other alternative shaped can be used and employed within the ventilationinterface 100. This connector 270 also includes one or more bleed ports280 (as further shown in FIG. 3C) of sufficient size and dimension toallow the patient to exhale the breathable gas supplied by a flowgenerator. The bleed ports 280 can be a plurality of holes 281 orientedwithin the connector 270 to minimize noise while dispersing the expelledair. However, in other embodiments contemplated by the invention, thesebleed ports 280 can be located on other portions of the ventilationinterface 100 including, but no way limited to, the cannula 300.

FIGS. 3A and 3B illustrate one preferred form of the cannula 300. Whileone of ordinary skill in the art will recognize various forms ofcannulas sufficient to effectuate a seal with the nares of the patient,the preferred cannula 300 includes a reservoir 310 (best shown in FIG.4). The reservoir 310 is formed through a first side wall 315, acorresponding second side wall 320, a top wall 330, a correspondingbottom wall 340, a front wall 350, and a back wall 360. However, thereservoir 310 can be of various sizes and shapes—and should not belimited to the orientation herein described. The first side wall 315 isessentially parallel to the second side wall 320 and has essentially thesame size and dimension. Positioned on the top wall 330 are one or morenasal prongs 370. The nasal prongs 370 can take many a form aspreviously discussed and described in greater detail below.

The nasal prongs 370 and various walls 320-360 form one integral singlecannula 300. By having an integral cannula, assembly and disassembly aresimplified for the patient, the cannula size is reduced and leak betweenwalls and separate cannula parts is eliminated. Although preferably madeof a low durometer silicone elastomer, the cannula 300 can be made ofplastic, composite or any similar material known to those of ordinaryskill in the art.

Referring now to FIG. 3A, located on the front wall 350 of the cannula300 is an aperture 380. The aperture 380 may be circular and includes anengagement area 381 for fluidically connecting with the ventilation tube200. The connection may be in the form of a press fit, mating flange,threads, clips, or any connection method known to those of ordinaryskill in the art. The engagement area 381 is of sufficient size anddimension to connect and maintain the socket 260 or the connector 270,depending on the embodiment.

The Cannula and Nasal Prongs

FIG. 3C offers a more detailed perspective of the preferred cannula 300.As shown, the top wall 330 of the cannula 300 includes a first portion331 and a corresponding second portion 332. Positioned between the firstportion 331 and second portion 332 is a notch 333. Located on the firstportion 330 is a first nasal prong 371. Likewise, a second nasal prong372 is located on the second portion 332 of the top wall 330. Both nasalprongs 371 and 372 have essentially the same size and dimension. Thenotch 333 allows for clearance of the bottom of the patient's nose.Further, notch 333 allows the top wall 330 of the cannula 300 to flexinward. The act of inwardly flexing both the first portion 331 andsecond portion 332 helps orient and position both nasal prongs 370 inrelation to the opening of the nares of the patient.

FIG. 3C further shows one general orientation of the nasal prongs 370.Here, the nasal prongs 370 are illustrated as nasal pillow style nasalprongs. As shown, each nasal prong 370 includes a top sealing member375. The sealing member 375 is essentially elliptical in cross section.At the distal tip of the top sealing member 375 is an opening 377. Theopening 377 allows breathable gas to flow from the ventilation tube 200into the reservoir 310 of the cannula 300 and ultimately to the patient.As illustrated in FIG. 3C, the sealing members 375 of both nasal prongs370 inwardly tilt toward each other.

In addition, FIG. 3C also shows one orientation for the bleed ports 280located on the connector 270. In the preferred embodiment, the connector270 includes an essentially flat portion 271 having one or more bleedports 280. In one contemplated arrangement, the bleed ports 280 arecloistered and arranged in a plurality of rows having multiple bleedports 280. The bleed ports 280 are sufficient to allow breathable gasrespired from the patient to leave the ventilation interface 100.

FIG. 4 offers a cross-sectional view of the cannula 300, the ventilationtube 200, the socket 260 and the connector 270. In addition, FIG. 4shows how a ball 261 is disposed at one distal end of the connector 270.The ball 261 engages a socket 260. The ball 261 both pivots and rotateswithin the socket 260 and helps orient the ventilation tube 200.

The Headgear

FIGS. 5A and 5B offer a more detailed view of the preferred headgear500. FIG. 5A provides a side view of the headgear 500, as well as thecannula 300, connector 270 and the ventilation tube 200. As shown (andpreviously discussed above), the headgear 500 includes a first strap 510and a corresponding second strap 520. FIG. 5A illustrates the firstportion 530 of the first strap 510, showing both the inner layer 511 andouter layer 512. It is noted that the second portion 540 (shown in FIG.5B) of the first strap 510 is a mirror image of first portion 530, andtherefore has all of the same components and functionality found in thefirst portion 530.

The inner layer 511 includes three component sections 513-515, eachintegrally connected to one another at a different angle. These includea first section 513, a second section 514, and a corresponding thirdsection 515. It is preferable that the inner layer 511 is cut from asingle piece of material such that all three sections 513-515 are asingle piece. During use, the first section 513 is positioned over theback of the head, the second section 514 is positioned between the earand the eye, and the third section 515 extends towards the cannula 300.

FIG. 5A also shows one preferred structure for the outer layer 512 ofthe first portion 530. Like the first portion 511, the outer layer 512may include three outer sections: first outer section 516, second outersection 517, and third outer section 518. These three outer sections516-518 mirror the orientation of the first section 513, second section514 and corresponding third section 515 of the first portion 511described above. Positioned where the first outer section 516 meets thesecond outer section 517 is at least one slot 560.

As further illustrated in FIG. 5A, preferably there are two slots 560: afirst slot 561 and a second slot 562. The first slot 561 is oriented andplaced at a different angle in comparison to the second slot 562. Thisallows the second strap 520 to be attached to either slot 560 at adifferent orientation so to assist in properly fitting the interface 100to the patient.

FIG. 5B provides a front view of the interface 100 and illustrates oneversion of the preferred second strap 520 of the headgear 500. Thesecond strap 520 includes a first end 525 and a corresponding second end526. In addition, a tube holder 524 is positioned on the middle portion523 of the second strap 520. The tube holder 524 is capable ofmaintaining the ventilation tube 200 during use of the interface 100 bythe patient.

Positioned at both ends 525 and 526 of the second strap 520 arefasteners 527, which are preferably a hook-and-loop fastener. Eachfastener 527 engages a slot 560, located on the first strap 510,sufficient to attach the second strap 520 onto the first strap 510 toform the headgear 500. Moreover, each fastener 527 can be periodicallyadjusted about either slot 560, including while wearing the interface100, such that the cannula 300 is properly oriented and sealed inrelation to the patient.

The Arced Coupler

FIGS. 6A through 6E provide several embodiments regarding how theheadgear 500 is preferably attached to the cannula 300. First turning toFIG. 6A, the cannula 300 includes a first side wall 315 and acorresponding second side wall 320 (best shown and illustrated in FIG.3B). Positioned on the first side wall 315 is a curved female sleeve 390and positioned on the corresponding second side wall 320 is acorresponding curved female sleeve 391. It is noted that the curvedfemale sleeves 390 and 391 have all of the same features andfunctionality. It is also understood that a curved female sleeve couldbe located on any of the walls of the cannula 300 or even throughcannula 300 itself, as long the reservoir 310 remains sealed.

Each curved female sleeve 390 and 391 is capable of receiving andengaging a curved male tine 395 and 396 respectively. Both curved maletines 395 and 396 are located on the third outer sections 518respectively of the headgear 500. The combination of a curved femalesleeve and a curved male tine forms an arced coupler 398 which attachesthe headgear 500 onto the cannula 300.

FIG. 6B illustrates a cross sectional view through curved female sleeve390 prior to assembly of the curved male tine 395. FIG. 6C illustrates across sectional view of an arced coupler 398 (shown in FIG. 6C) (i.e.the curved male tine 395 assembled to the curved female sleeve 390). Asis shown in FIG. 6B, curved female sleeve 390 contains a cavity 392 ofsufficient size and dimension to engage and secure the curved male tine395.

As best shown in FIG. 6C, curved male tine 395 can move in an arc pathwithin curved female sleeve 390, allowing cannula 300 to rotate relativeto headgear 500 and therefore allow the user to adjust the location ofthe nasal prongs 370. Also, if the user desires, cannula 300 can beremoved from headgear 500 by simply moving cannula 300 further away fromthe face until curved male tine 395 decouples from curved female sleeve390.

As opposed to the prior art, this can be done without the user removingthe interface from the face. Also as opposed to the prior art, thisallows the user to continue to wear the headgear 500 without the cannula300. Optionally, the distal end of each curved male tine 395 and 396 caninclude a catch 394. This catch 394 can engage a ledge 393 on the curvedfemale sleeve 390 at one specific angle of rotation to further preventthe incidental removal of the curved male tine 395. If enough force isapplied however by the user, the catch 394 can disengage from the ledge393.

FIG. 6D and FIG. 6E offer a second embodiment of the arced coupler 400.First turning to FIG. 6D, this arced coupler 400 includes a curvedfemale slot 401 located on each of the third outer sections 518 of theheadgear 500. Adjacent the curved female slot 401 is a squared opening404 that is sufficiently larger than the curved female slot 401.

As further shown in FIG. 6D, in this embodiment of the ventilationinterface 100, both the first side wall 315 and corresponding secondside wall 320 of the cannula 300 include a male member 410. The malemember 410 can include stem 411 and a larger head 412. The head 412 ofthe male member 410 is capable of fitting within the squared opening 404of the female slot 401 during assembly and disassembly of the headgear500 from the cannula 300.

Once positioned beyond the squared opening 404, the stem 411 can glidewithin the curved female slot 401 of the headgear 500, allowing forangular adjustments of the cannula 300 relative to the headgear 500.While the stem 411 is within the curved female slot 401, the head 412prevents the male member 410 from disengaging from the curved femaleslot 401 in a direction normal to surface 415 of the headgear 500.Combination of the male member 410 with the curved female slot 401 formsthe second embodiment of the arced coupler 400.

One additional optional feature contemplated by the invention is that ofan axis for rotational adjustment that passes through or above eachnasal prong 370. In an embodiment where the axis passes through thenasal prongs 370, the nasal prongs 370 only rotate and therefore do notchange position (i.e., translate and rotate as would occur if the axiswere below the nasal prongs 370) relative to the headgear 500 duringangular adjustment. This way, an angular adjustment can be made withoutadditional adjustments to the headgear. The embodiments shown in FIGS.6A to 6E all have an axis 305 that passes through the nasal prongs 370.In these embodiments, the location of the axis 305 is a result of thearced couplers. The location and curvature of the arced couplers 398 or400 can be modified in design to move the location of the axis 305 sothat it passes through or above the nasal prongs 370.

Detachable Nasal Prongs

The invention is further directed towards detachable and adjustablenasal prongs. These alternative nasal prongs are preferably made of asoft, pliable, compressible and biocompatible material such as siliconeelastomer. However, one of ordinary skill in the art will recognizeother similar materials that can be used. FIG. 3 illustrates nasalprongs 370 that are integral to cannula 300. In these embodiments, thenasal prongs 370 may be detachably coupled with the cannula 300, as isdescribed in detail in the aforementioned referenced patent applicationsidentified above. Detachable nasal prongs may have a differentdurometer, such as a lower durometer, or be made of a different materialthan other portions of the cannula.

FIGS. 7A, 7B, 8A, and 8B illustrate two different embodiments for adetachable nasal prong. First turning to FIGS. 7A and 7B, the detachablenasal prong 770 includes a first prong portion 771 and a second prongportion 772. Here, each prong portion is illustrated as a nasal pillowstyle nasal prong in a non-limiting manner. First prong portion 771 hasa first sealing member 775 and second prong portion 772 has a secondsealing membrane 776. Depending on which prong portion is orientedtowards the patient, one of the first or second sealing members engagesthe nares. At the tip of first prong portion 771 is a first opening 777and at the tip of the second prong portion 772 is a second opening 778.Both the first and second openings are capable of providing pressurizedbreathable gas to the patient.

Located in nasal prong 770 is a ringed member 783, which includes afirst ring 784, a recess 785, and a corresponding second ring 786. Theringed member 783 is capable of engaging an aperture 387 (shown in FIG.9B) located within the first portion 331 and second portion 332 of thecannula 300. Put another way, the ringed member 783 is of a sufficientsize and dimension so as to fit and seal within the aperture 387provided on the top wall 330 of the cannula 300. A connection betweenthe nasal prong 770 and the aperture 387 may be in the form of a pressfit, mating flange, threads, clips, or any connection method known tothose of ordinary skill in the art.

FIG. 7B provides a cross sectional view of the detachable nasal prong770 illustrated in FIG. 7A. Here, the second sealing member 776 islarger in size and dimension in comparison to the first sealing member775. Likewise, the second opening 778 may be larger than the firstopening 777.

The nasal prong 770 illustrated in both FIG. 7A and FIG. 7B furtherenhances the adjustability of the cannula 300. Should the patient havesmall nares, the cannula 300 is fitted with nasal prongs 770 such thatthe first sealing member 775 is oriented to contact the nares, while thesecond sealing portion 776 is positioned within the cannula 300. Shouldthe patient have large nares, then each nasal prong 770 is turned 180degrees such that the second sealing member 776 is oriented to contactthe nares, while the first sealing portion 775 is positioned within thecannula 300. Should the patient have different sized nares, each nasalprong 770 could be oriented differently to provide the sizing needed toprovide a comfortable seal.

FIGS. 8A and 8B show another similar embodiment of a detachable nasalprong. The detachable nasal prong 870 includes a first prong portion871, a second prong portion 872, and a third prong portion 873. Thisembodiment illustrates that more than two nasal portions can be locatedon a detachable nasal prong 870. This embodiment also illustrates thateach nasal prong portion can be of a different size, or even of adifferent type of nasal prong. For example, first prong portion 871 canbe a nasal pillow style nasal prong, the second prong portion 872 can bea nasal pillow style nasal prong that is smaller than the first prongportion 871, and the third prong portion 873 can be a nasal insert stylenasal prong. First prong portion 871 has a first sealing surface 875,and third prong portion 873 has a third sealing surface 877. Secondprong portion 872 may have a seal component 876 that is coupled to it.Seal component 876 may be a different durometer or material than secondprong portion 872. For example, second prong portion 872 may be siliconeand seal component 876 may be constructed of foam or gel.

Similar to nasal prong 770, each prong portion of nasal prong 870 has aringed member 883, which is capable of engaging an aperture 387 locatedwithin the first portion 331 and second portion 332 of the cannula 300(all shown in FIG. 9B). Depending on which prong portion is positionedtowards the patient, one of the first, second, or third prong portionsengages the nares while the other two remaining prong portions would bewithin the cannula 300. Detachable nasal prongs 770 and 870 could alsobe adapted to couple with any mask that has nasal prongs, includinghybrid masks (i.e., those masks that combine masks such as having anoral cavity with nasal prongs).

FIGS. 9A, 10A, 10B, and 10C offer additional structure that can beapplied to a nasal prong, such as the integral nasal prong 370 or thedetachable nasal prong 770. FIG. 9A illustrates a nasal prong 970, whichis shown to be detachable in a non-limiting way. The sealing member 975includes an upper portion 999, which is located at the distal tip of thenasal prong 970 and which has an opening 920. The upper portion 999 maybe adjustable.

FIGS. 10A, 10B, and 10C illustrate cross-sections of differentconfiguration of the nasal prong 970. In FIG. 10A, upper portion 999 isshown adjusted to be fully extended. In this configuration, the upperportion 999 extends further into the nose of the patient during use. Inthis configuration, the upper portion 999 serves several purposes. Firstthe upper portion 999 minimizes the opportunity for the nasal prong 970to inadvertently become dislodged from the patient's nose. Second, theupper portion 999 helps the flow of the breathable gas become laminar inorder to improve patient comfort.

Upper portion 999 could also fold or roll inwardly. This adjustmentcould shorten the length of the upper portion 999, could decrease thesize of the opening 920, or could change the size or shape of thesealing member 975. FIG. 10B illustrates one example of an embodimentwhere the upper portion 999 has been folded inwardly. Upper portion 999could also fold or roll outwardly. This adjustment could shorten thelength of the upper portion 999, could increase the size of the opening920, or could change the size or shape of the sealing member 975. FIG.10C illustrates one example of an embodiment where the upper portion 999has been rolled outwardly. A rolled or folded upper portion 999 couldalso serve to create a sealing bead 990, as shown in FIG. 10C. Furtheradjustment of the upper portion 999 would further adjust the size andshape of the sealing bead 990.

FIGS. 11A and 11B illustrate another embodiment regarding how theheadgear 500 is attached to the cannula 300. FIG. 11A shows the cannula300 disassembled from the headgear 500. In this embodiment, cannula 300has back wall 360 that contains a receptacle 590, and headgear 500 has apin 580 that is located between the first portion 530 and the secondportion 540. In embodiments, receptacle 590 could be located on anyportion of the cannula 300 and could be embedded within or protrude fromcannula 300. Pin 580 is configured to fit into receptacle 590 andprovides for easy assembly and disassembly of the cannula 300 from theheadgear 500. For example, the user could remove the cannula 300 whilestill wearing the headgear 500.

FIG. 11B is a cross-section of the embodiment when assembled. Pin 580 isconfigured to allow the user to make angular adjustments to the cannula300 with respect to the headgear 500 for improved fitting and comfort.Pin 580 is preferably made of a harder material than cannula 300 andcould be pushed into the receptacle 590 during assembly. Pin 580 ispreferably circular in cross-section to allow for rotation with respectto the receptacle 590. The friction fit between the pin 580 and thereceptacle 590 would allow the user to place the cannula 300 in aninfinite number of angular positions.

The pin 580 could have an alternate cross-sectional shape or havedetails to allow the cannula to rotate to a predetermined number ofpositions. For example, the pin 580 could be egg shaped, square, hexshaped, or any other shape. The pin 580 could have divots, slots, bumps,ratchets, cams, or other types of details. The receptacle 590 may have acorresponding shape or details to engage the pin 580. The shapes anddetails described for the pin 580 could be applied to the receptacle 590instead and the details of the receptacle 590 could be applied to thepin 580 instead, as would be recognized by those having ordinary skillin the art. In embodiments, a secondary part (not shown), such as abushing, could be located between the pin 580 and the receptacle 590.

Preferably, the pin 580 is fixed to the headgear 500 and the cannula 300rotates about pin 580. In an alternate configuration, the pin 580 couldbe assembled to the headgear 500 in a manner that allowed it to rotatewithin the headgear. For example, the pin 580 could fit into holes (notshown) in the headgear 500. Either configuration ultimately allows theuser to rotate the cannula 300 with respect to the headgear 500. In thisalternate configuration, it is understood that the methods and detailsdescribed above pertaining to the pin 580, the receptacle 590, and theirconnection could be applied to the pin 580, the holes (not shown) in theheadgear, and their connection.

FIG. 12 illustrates a handle 1250, which could be utilized onembodiments to assist in rotating the cannula 300. The handle 1250provides the user with additional leverage and an easier feature tograsp to facilitate fitting or calibration. The handle 1250 could alsofunction as a key, allowing the cannula 300 to only move relative to theheadgear 500 if the handle 1250 is engaged. The handle 1250 could beengaged by insertion, twisting, by pressing or releasing a button, orany other method recognized by those having ordinary skill in the art. Ahandle 1250 that is detachable is preferred so it could be constructedin any manner, out of any material, or any size that provided the mostleverage. While the handle 1250 could be integral, a detachable handle1250 could be removed prior to the patient lying down as to notinterfere with the comfort of using the interface.

FIG. 13 shows yet another embodiment of a headgear for the ventilationinterface. Headgear 1300 has a first strap 1310 and a second strap 1320.Headgear 1300 also has a center strap 1330 that connects to the secondstrap 1320. Center strap 1330 has a nose portion 1340, which goes overat least a portion of the nose. At the base of the nose portion 1340 isa connecting portion 1350. Connecting portion 1350 is configured tocouple with the ventilation interface. Connecting portion 1350 has atleast one aperture 1360 that could engage with the nasal cannula 300 ordirectly with the nasal prongs 370. By tightening any of the first strap1310, the second strap 1320, or the center strap 1330, the nasal prongswould engage with nares of the patient to create a comfortable seal.This tightening would create an upward sealing force on nares from thenasal prongs.

The connecting portion 1350 could be configured to couple with othertypes of mask seals, such as facial cushions, and allow for the patientto create a comfortable seal with the face. Similar to the materials ofthe headgear 500, the materials of headgear 1300 are preferably soft andflexible, such as the fabrics discussed previously. Polymers, such assilicone or rubber, could also be utilized in the headgear 1300. Noseportion 1340 is preferably made of silicone.

1-23. (canceled)
 24. A respiratory interface comprising: a cannulahaving at least one coupler; at least one nasal prong coupled with thecannula; and a headgear having at least one connector adapted to beattached to the at least one coupler of the cannula; and wherein anangle of the at least one nasal prong relative to the headgear is variedby a relative position between the connector and the coupler.
 25. Therespiratory interface of claim 24, wherein the at least one nasal prongis located on a top wall of the cannula.
 26. The respiratory interfaceof claim 24, wherein the at least one coupler includes at least onefemale sleeve.
 27. The respiratory interface of claim 24, wherein the atleast one coupler is on a side wall of the cannula.
 28. The respiratoryinterface of claim 24, wherein the at least one connector of theheadgear includes at least one male tine.
 29. The respiratory interfaceof claim 28, wherein the at least one male tine includes at least oneposition indicator.
 30. The respiratory interface of claim 24, furthercomprising a ventilation tube coupled to the cannula.
 31. Therespiratory interface of claim 30, wherein the ventilation tube iscoupled to the cannula via a ball-and-socket connector.
 32. Therespiratory interface of claim 24, wherein the respiratory interfacefurther includes at least one bleed port.
 33. The respiratory interfaceof claim 24, wherein the at least one nasal prong is removably coupledto the cannula.
 34. The respiratory interface of claim 24, wherein theat least one nasal prong includes at least one sealing portion.
 35. Therespiratory interface of claim 24, wherein the at least one nasal prongincludes an adjustable upper portion with an opening located at a distaltip of the nasal prong.
 36. A respiratory interface comprising: acannula having at least one coupler; at least one nasal prong coupledwith the cannula; and a headgear having at least one connector adaptedto be slidably inserted into the at least one coupler of the cannula;and wherein a position of the cannula relative to the headgear isaccomplished by varying an insertion depth of the connector into thecoupler.
 37. The respiratory interface of claim 36, wherein the at leastone nasal prong is coupled with a top wall of the cannula.
 38. Therespiratory interface of claim 36, wherein the at least one coupler ofthe cannula includes at least one female sleeve.
 39. The respiratoryinterface of claim 36, wherein the at least one connector of theheadgear includes at least one male tine.
 40. A respiratory interfacecomprising: a cannula having at least one female coupler: at least onenasal prong coupled with the cannula; and a headgear having at least onemale coupler adapted to be slidably inserted into the at least onefemale coupler along a curved path.
 41. The respiratory interface ofclaim 40, wherein the at least one nasal prong is coupled to a top wallof the cannula.
 42. The respiratory interface of claim 40, wherein theat least one female coupler includes at least one female sleeve.
 43. Therespiratory interface of claim 40, wherein the at least one male couplerincludes at least one male tine.